the fine art of corneal and refractive surgery

THE FINE ART OF
CORNEAL AND
REFRACTIVE SURGERY
S e e l i a b i l i t y l i m i t a ti o n o n th e l a s t p a g e.
www.dioptex.com
HISTORY OF
DIOPTEX
2003
Dioptex was founded in 2003 by Dr. Albert Daxer
as a research and developmental company. It is a
spin-off of his scientific work at the Department of
Ophthalmology, University of Innsbruck, Austria.
Dr. Daxer introduced the Corneal Pocket Concept
(CPC) as a general surgical principle into corneal
surgery, and designed and developed the related
tools and internationally patented high-end devices
such as PocketMaker Ultrakeratome, PocketMaker
Artificial Anterior Chamber, disposable Micro-CXL,
MyoRing intra-corneal implant for the treatment of
Keratoconus and Myopia as well as the related surgical procedures.
The PocketMaker, an internationally patented Ultrakeratome of incomparable precision and safety for
the creation of corneal pockets is the starting point
for many applications related to the new surgical
concept. It can be considered as a revolutionary
step in the development of corneal surgery. In contrast to conventional technologies such as mechanical LASIK microkeratomes and Femtosecondlasers,
the PocketMaker Ultrakeratome marks the latest innovation step in the development of corneal cutting
technology. The PocketMaker Ultrakeratome uses
a new cutting principle based on a most innovative
ultra-high precision diamond technology that guarantees incomparable quality of corneal cutting.
2007
CISIS (Corneal IntraStromal Implantation Surgery), the first surgical application of this revolutionary new corneal technology was introduced by
Dr. Daxer in 2007 at ESCRS in Stockholm. CISIS
combines the PocketMaker Ultrakeratome cutting
of corneal pockets with the implantation of a new
2
innovation
kind of corneal implant (MyoRing) into the corneal
pocket for the treatment of Myopia, Keratoconus
and post-LASIK Keratectasia.1,2 In order to achieve the best possible result in every given case, the
internationally patented MyoRing is an innovation
designed to combine two a priori opposite qualities: It is rigid but also compressible to allow both,
visual rehabilitation and implantation into a corneal
pocket via a small incision.
2008
Dr. Haifa Mahmood of Bahrain and Prof. Jorge Alio
of Alicante, Spain performed the first CISIS with
MyoRing implantation using Femtosecondlaser
technology. 3,4
Dr. Daxer introduced a new surgical procedure for
corneal crosslinking according to the CPC using
the PocketMaker Ultrakeratome technology:
Pocket CXL. 5
1 Daxer A. Corneal intrastromal implantation surgery for the
treatment of moderate and high myopia. J Cataract Refract Surg
2008;34:194-198.
2 Daxer A. Adjustable Intracorneal Ring in a Lamellar Pocket in
Keratoconus. J Refract Surg 2010;26:217-221.
3 Mahmood H, Venkateswaran RS and Daxer A. Implantation of
a Complete Corneal Ring in an Intrastromal Pocket for Keratoconus. J Refract Surg 2011;27:63-68.
4 Alio JL, Pinero DP and Daxer A. Clinical Outcome After Complete Ring Implantation in Corneal Ectasia using the Femtosecond Technology. Ophthalmology 2011;118:1282-1290.
5 Daxer A, Mahmood H and Venkateswaran RS. Corneal Crosslinking and Visual Rehabilitation in Keratoconus in One Session
Without Epithelial Debridement: New Technique. Cornea
2010;29:1176-1179.
In this new procedure Riboflavin is injected
into the corneal pocket at 300 microns corneal depth for 2 minutes and then irradiated by
UV-A light. This new approach avoids pain and
healing problems of conventional treatment and
reduces the time for surgery and UV-A exposure
dramatically. In contrast to conventional epi-off
crosslinking which requires 5.4 J/cm 2 total UV-A
energy transferred to the cornea, the surgeon
can achieve the same effect with only 2.1 J/cm 2
total UV-A energy transferred to the cornea when
performing Pocket CXL. And the very best, this
procedure can be combined with MyoRing implantation in the same surgical session to achieve not
only stop of Keratoconus progression but also visual rehabilitation.
For optimal crosslinking results the revolutionary DIOPTEX Micro-CXL technology was developed and
launched as disposable Mirco-CXL at the ESCRS
in Amsterdam 2013. It uses a superior disposable
Micro UV-A with many most innovative features.
DIOPTEX DISPOSABLE MICRO-CXL with the integrated MAGIC TOUCH technology can simply be
called THE INNOVATION OF THE YEAR 2013!
A further revolutionary development based on the
PocketMaker Ultrakeratome technology is ISKE
(IntraStromal Keratectomy) for the removal of an
intrastromal tissue lenticule without a flap for the
treatment of high myopia.
2010
Dr. G.M. Bikbova and Prof. M.M. Bikbov, Ufa Eye
Research Institute, Ufa, Russian Federation, performed the first PocketMaker Endothelial Keratoplasty procedure. 6
2011
Dr. Pavel Studeny of Czech Republic performed the
first PocketMaker Keratoprothesis procedure.
2013
DIOPTEX launched the patented PocketMaker Artificial Anterior Chamber (AAC) at the ESCRS in Amsterdam. This superior technology, developed by Dr.
Daxer is a revolutionary step in the development of
safe and precise DALK and Endothelial Keratoplasty
techniques as well as in modern eye-banking.
6 Bikbova G, Bikbov M and Daxer A. Descemet Stripping
PocketMaker Endothelial Keratoplasty. Int J Kerat Ect Cor Dis
2012;1(2):125-127.
3
CORNEAL
POCKET
CONCEPT
ONE POCKET MANY APPLICATIONS
As a result of this biomechanical know-how a corneal pocket is the absolutely right structure in corneal surgery since it preserves the corneal biomechanics, independent of the pocket’s dimension.
This is in contrast to a non-lamellar surgery like
e.g. a lasik flap, which definitely destroys biomechanics and weakens the cornea .
In this concept, the cor neal pocket, preferably
created by the PocketMaker Ultrakeratome is the
starting point for many new applications and surgical solutions.
Mother nature developed the cornea of the
human eye according to the optical and biomechanical needs as a very regular ordered collagen
tissue to achieve the right dipotic power, perfect
transparency, immunological privilege and biomechanical strength. 7 In particular the structure and
lamellar arrangement of the collagen is the basis
of the biomechanical framework of the cornea. 8,9
ISKE
Myopia
CISIS
Presbyopia
CISIS
Myopia
PocketMaker
Pocket LKP
Lamellar
Keratoplasty
Therefore, the CORNEAL POCKET CONCEPT
is the natural and most appropriate surgical approach to the lamellar nature of this particular tissue. The CORNEAL POCKET CONCEPT is based
on the creation of a lamellar intra-corneal pocket
without a significant alteration of the collagen lamellar structure.
CISIS
Keratoconus
Pocket CXL
Keratoconus
7 Fratzl P and Daxer A. Structural transformation of collagen
fibrils in corneal stroma during drying: An x-ray scattering study.
Biophys J 1993;64:1210-1214.
8 Daxer A and Fratzl P. Collagen fibril orientation in the human
corneal stroma and its implication in keratoconus. Invest Ophthalmol Vis Sci 1997;38:121-129.
9 Daxer et al. Collagen fibrils in the human corneal stroma:
structure and ageing. Invest ophthalmol Vis Sci
1998;39:644-648.
4
5
precision &
safety
POCKETMAKER
ULTRAKERATOME
The PocketMaker Ultrakeratome is an internationally patented device which sets a new
standard in corneal cutting technology. It is in
its precision, safety as well as number and kind of
applications superior to all other existing corneal
cutting technologies including mechanical Microkeratomes and Femtosecondlaser Microkeratomes.
The PocketMaker Ultrakeratome is the core device
for the surgical application of the CORNEAL POCKET CONCEPT. It allows the creation of almost
entirely closed corneal pockets of up to 9 mm in
diameter at any corneal depth.
The entire device fits into a case which is easy to
carry. Among others this feature is the result of
implementing the latest micro-technology into the
system.
The creation of the pocket using the PocketMaker
Ultrakeratome is a very safe procedure which is
quick and easy to perform. It requires topical anesthesia only. The entry to the pocket is self-sealing
and no suture is required.
The depth of the pocket is defined by the dimension of the disposable transparent applanator. The
applanator has a magnification lens and, therefore,
no surgical microscope is required. The PocketMaker Ultrakeratome gives the surgeon full visual and
interventional control during the entire procedure.
6
The unique PocketMaker Ultrakeratome cutting
technology uses an ultra-thin, on micron-level
guided single-crystal diamond with cutting edges
sharpened on atomic level even and driven by a
unique, sterilizeable vibration micro-engine.
This superior corneal cutting technology guarantees the cutting of most perfect corneal pockets
where the cutting interface is that smooth and of
such a extraordinary quality that the corneal cut
itself cannot even be easily recognized via a regular surgical microscope.
The photos show the situation immedatley after
pocket creation.
corneal pocket
using Femtosecondlaser
technology
PocketMaker
Ultrakeratome
diamond
technology.
7
MYORING FOR MYOPIA
MYORING INTRACORNEAL IMPLANT
The MyoRing is particularly designed to cover the
entire myopic range from -1 to -20 diopters.
The MyoRing is an internationally patented intracorneal implant for the treatment of Keratoconus and Myopia. The MyoRing is a complete-ring
shaped implant and a unique device since it combines two a-priori conflicting features which normally exclude each other:
The implant is rigid enough to maintain the stabilisation of the cornea and flexible (compressible)
enough to be introduced into a corneal pocket via
a small incision. It has also a shape-memory in
order to reshape to the original shape within the
pocket after implantation.
The INDICATIONS for MyoRing treatment of Myopia
are those not eligible for Excimer Laser treatment
such as:
high myopia
thin cornea
irregular corneal surface forme fruste
forme fruste keratoconus
the patient denies LASIK but
wants a minimally-invasive
and reversible myopia treatmen
Since the alternatives to Excimer Laser surgery in
these cases are intraocular procedures with significant side effects and long-term complications, 10
CISIS (MyoRing implantation) for Myopia offers a
minimal-invasive, reversible, safe and easy to perform alternative to the intraocular procedures.
The number of patients found to be not eligible for
Excimer Laser surgery usually exceeds 15 % of the
patients interested in Laser Vision Correction.
MyoRing implantation for Myopia, therefore, allows
Laser Vision Centers to cover at least a significant
number of this huge diagnostic drop-out rate.
minimally
invasive
10 Torun N et al. Posterior chamber phakic intraocular lens to
correct myopia: Long-term follow-up. J Cataract Refract Surg
2013;39:1023-1028.
8
9
MYORING
FOR KERATOCONUS
In contrast to conventional corneal implant techniques such as intra-corneal ring segments which
are captured in corneal tunnels and which allow
the surgeon access to only one degree of freedom
(implant thickness), the MyoRing intra-corneal implant, implanted into a pocket which is usually larger in diameter than the diameter of the MyoRing,
gives the surgeon access to all 3 theoretically possible degrees of freedom of corneal implant surgery
(implant thickness, implant diameter and implant
position). Therefore, this superior kind of surgery
allows the surgeon to achieve the best possible result in every given case.
optical axis preoperatively. In other words, nobody
knows the right placement of an intra-corneal implant preoperatively. 2 Shifting the MyoRing by only
0.5 mm can lead to a dramatic improvement of the
result. 2
Keratoconus, especially if combined with Pocket
CXL which increases the effect of the implant in
advanced cases.
It can be used to treat central and non-central cones
as well as post LASIK-Ectasia. 14
central cone
In particular the possibility to change the position
of the MyoRing implant relative to the optical axis
within the 9 mm corneal pocket is of outmost clinical
importance for the following reason: A concentric
preparation of a corneal tunnel around the postoperative optical axis is not possible since the postoperative optical axis is not known preoperatively and
the postoperative optical axis is also different to the
Without using these kinds of optimisation possibilities of CISIS the mean improvement of uncorrected
visual acuity in moderate to advanced keratoconus
cases using the regular nomogram is about 6 lines
(logMAR). 11,12 These resutls can be significantly
improved to more than 10 lines if a postoperative
optimisation step, which can be necessary in up to
20 % of the cases, is performed. 2,11,12,13 The right
analysis of the postoperative results and the related
decision making in order to achieve the best results
in every given case is part of an intensive training
program for the surgeon at DIOPTEX. This particular training program consists of several steps including theoretical lectures, wetlab training, assisted
surgery as well as preoperative and postoperative
online consultation.
CISIS can be successfully applied to all grades of
non-central cone
As the MyoRing is a full (360°) ring implant with no
free ends, the extrusion rate is in contrast to ring
segments almost zero.
individually
11 Daxer B, Mahmood H, Daxer A. MyoRing Treatment for Ke-
ratoconus: DIOPTEX PocketMaker vs. Ziemer LDV for Corneal
Pocket Creation. Int J Kerat Ect Cor Dis 2012;1(3):151-152.
12 Jabbarvand M et al. Continous intracorneal ring implantation
for keratoconus using femtosecond laser. J Cataract Refract
Surg 2013;39:1081-1087.
13 Daxer A, Mahmood H and Venkateswaran RS. Intracorneal
continous ring implantation in Keratoconus: One-year follow-up.
J Cataract Refract Surg 2010;36:1296-1302.
14 Daxer A. MyoRing for Central and Noncentral Keratoconus.
Int J Kerat Ect Cor Dis 2012;1(2):117-119.
10
11
POCKET CROSSLINKING
(POCKET CXL)
Pocket Crosslinking means corneal crosslinking
by applying Riboflavin to the cornea via a PocketMaker corneal pocket at preferably 300 microns
depth to bypass the epithelium. 5
After creation of the corneal pocket using the
PocketMaker Ultrakeratome Riboflavin is injected
into the corneal pocket via the small entry tunnel
for anly 2 minutes. This most effective procedure avoids postoperative pain and discomfort since
the epithelium is not touched.
The optimal depth for the placement of the corneal pocket was found to be 300 microns since
this placement reduces the required total UV-A
energy transfer to the cornea to about 2.1 J/cm 2
compared to 5.4 J/cm 2 of the conventional epi-off
technique.
For this particular kind of treatment the UV-A exposure time can be significantly reduced according to the Daxer-Formula
UV – A exposure time (minutes) =
effective
36
UV – A intensity
mW
( cm
)
2
Pocket CXL can (or should) be combined with Myo
Ring implantation by placing both into the same
corneal pocket, Riboflavin and MyoRing. 5
Pocket-CXL combined with MyoRing implantation
can achieve both in one surgical session: stop of
progression and visual rehabilitation. And all this
without postoperative pain and significantly reduced UV-A energy transfer.
One day after
combined surgery
Riboflavin
injection
12
13
INNOVATION
OF THE YEAR 2013
Dis pos able
Micro-CXL
DIOPTEX
DISPOSABLE
MICRO-CXL
This most innovative patented device is the first
CXL system based on integrated micro technology. It is a disposable single use system with many
fundamental advantages over existing systems
and marks the beginning of a new era in corneal crosslinking: So far Corneal Crosslinking (CXL)
was the field of large, expensive and heavy UV-A
sources. DIOPTEX disposable Micro-CXL is the
latest UV-A technology for Corneal Crosslinking.
The device is smaller than a tiny pen even and it
can be placed directly on the eye to avoid any effect of eye movement.
14
It can be carried simply in a pocket of a trousers or a
shirt. This device uses latest integrated micro technology and follows a „pay per procedure“ – philosophy. It is a single use disposable device and comes
in 2 versions:
1. a version with 5.4 J/cm 2 total energy transfer for
conventional epi-off Crosslinking.
2. a version with 2.1 J/cm 2 total energy transfer for
the most effective Pocket Crosslinking technique.
The system is very easy to use with its MAGIC
TOUCH technology but it is also adjustable according to the individual needs.
For instance, even the beam profile of the UV-A light
can be varied individually, if needed.
The particular main beam profile results in a shortening of the corneal lamellae anterior to the pocket
and the MyoRing.
Therefore, the system can either be used for the stop
of keratoconus progression only or as a refractive
procedure in combination with MyoRing implantation in order to achieve incomparable excellent visual
results in advanced keratoconus cases even.
15
LAMELLAR
KERATOPLASTY
Another important application of the CPC and
the PocketMaker Ultrakeratome technology is the
use of corneal pockets as a starting point for lamellar anterior and endothelial keratoplasty.
The patented PocketMaker Lamellar Keratoplasty
System (PMLKP) is a revolutionary development
which uses
1. the superior PocketMaker Ultrakeratome cutting technology,
2. a most precise stop-delimited
trephination technology for the host
cornea in order to limit the trephination
at the pocket level and
3. a PocketMaker Ultrakeratome artificial anterior chamber (PMAAC) in order
to apply the superior cutting technology of the PocketMaker Ultrakeratome
to the donor corneal button.
16
The fact, that the technology allows to safely cut
large pockets with perfect smooth interfaces as
close as 50 microns to the Endothelium will change
Lamellar Keratoplasty to a very safe, effective and
easy to perform procedure with a very low conversion rate. Since the PocketMaker technology allows
the surgeon to perform a corneal cut of any shape
it is also possible to cut even parallel to the posterior corneal surface – an important feature to avoid
peripheral transplant steps in Endothelial Keratoplasty.
A main problem when creating corneal pockets with
Femtosecondlaser technology as a starting point
for CISIS, keratoplasty or keratoprothesis is that
the corneal tissue is usually scary or turbid or may
have folds at least in a limited area. In such cases
incomplete Femtosecondlaser pockets are not rare.
The PocketMaker technology, however, is not sensitive to such limitations and incomplete cutted pockets are usually not seen since scars, turbidity or
folds do not affect the safety and effectiveness of
the PocketMaker Ultrakeratome cutting process. A
further problem in this kind of applications when
using the Femtosecondlaser technology is the fact,
that the localized tissue rupture of the laser shots
during tissue cutting have often to be applied deep
in the corneal stroma. However, the deeper the
Femtosecondlaser application the more imprecise
is the cutting and the more uncertain the result. In
contrast, the precision and quality of cutting of the
PocketMaker Ultrakeratome technology is independent of the cutting depth. Moreover, the PocketMaker is so precise that it can cut safely at least
50 microns close to the Endothelium with a most
perfect cutting interface.
17
PRESBYOPIA
As a result of the so far unreached corneal pocket
cutting quality, the PocketMaker Ultrakeratome is
the best choice for creating corneal pockets for
presbyopia inlay implantation.
In contrast to similar Femtosecondlaser approaches, where incomplete cuts are a risk for irreversible postoperative irregular astigmatism, 15 the PocketMaker Ultrakeratome technology avoids such
complications since it allows perfect smooth cutting interfaces as a result of the particular lateral
diamond technology.
future
ISKE
ISKE (Intrastromal Keratectomy) is a revolutionary
technology. The internationally patented system
uses the ultra-high precision and unique cutting
quality of the PocketMaker Ultrakeratome which
allows the cutting of two overlapping corneal pockets to separate an intrastromal tissue lenticule
from the remaining corneal stroma which can be
removed easily by a forceps via a small corneal
tunnel. The fact that no flap is needed preserves
the biomechanical stability of the cornea in comparison to LASIK.
15 Zixian D and Xingtao Z. Irregular astigmatism after
femtosecond laser refractive lenticule extraction.
J Cataract Refract Surg 2013;39:952-954.
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19
DIOPTEX GmbH
Baumbachstrasse 6
4020 Linz, Austria, EU
T + 43 -732 - 77 48 76
F +43 -732 - 77 48 764
[email protected]
www.dioptex.com
authorized distributor
Liability Limitation: This folder contains also scientific information which are not approved as
medical treatments. Therefore, DIOPTEX does not take any liability when informations given in
this folder are used by doctors for patient treatment.